Cleared Traditional

K850605 - RADI-BIOPSY DEVICE

K850605 is an FDA 510(k) clearance for RADI-BIOPSY DEVICE, manufactured by Radiplast AB. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K850605 · Radiplast AB · Gastroenterology & Urology device
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Aug 1985
Decision
175d
Days
Class 2
Risk

K850605 is an FDA 510(k) clearance for the RADI-BIOPSY DEVICE. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Radiplast AB (Kalamazoo, US). The FDA issued a Cleared decision on August 9, 1985 after a review of 175 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1075 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Radiplast AB devices

FDA 510(k) Submission Details - K850605

510(k) Number K850605 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 1985
Decision Date August 09, 1985
Days to Decision 175 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 130d · This submission: 175d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNW Device Classification - Class 2, Special Controls

Product Code KNW Instrument, Biopsy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1075
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KNW Instrument, Biopsy

All 174
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K850605.
BERAHA BIOPSY NEEDLES, 2N2730, 2N2731 & 2N2732
K855003 · Travenol Laboratories, S.A. · Feb 1986
MED SURG PERCUTANEOUS ASPIRATION BIOPSY(PAB)TRAY
K854291 · Medsurg Industries, Inc. · Nov 1985
MEDSURG PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAM
K854297 · Medsurg Industries, Inc. · Nov 1985
53-160 TO 53-167 VARIOUS BIOPSY FORCEPS YEOMAN
K851798 · Artiberia · May 1985
BONE BIOPSY SET
K820293 · The Anspach Effort, Inc. · Mar 1982
HEPAFIX BIOPSY NEEDLE SET
K813085 · Burron Medical Products, Inc. · Nov 1981